FDA.reportPublic FDA data

Cholestyramine

Product NDC
27241-134
11-digit product format
272410134
Labeler code
27241
Product ID
27241-134_52a1ce3a-88e1-4902-990d-c57cf9735e42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cholestyramine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA211119
Marketing category
ANDA
Marketing start
2020-04-06
Substance
CHOLESTYRAMINE
Active strength
4 g/9g
Pharmacologic classes
Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cholestyramine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHOLESTYRAMINE4 g/9g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B33BGI082
Rxcui848943

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bafdcfac-da3a-43c4-81f4-296b60084636Product name620250623

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-134-21Cholestyramine9 g in 1 PACKETPOWDER, FOR SUSPENSION96
27241-134-36Cholestyramine60 in 1 CARTONPOWDER, FOR SUSPENSION606
27241-134-51Cholestyramine378 g in 1 BOTTLEPOWDER, FOR SUSPENSION3786

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-134-51GM - Gram27241-134c37cb1c5-ca8e-4bb1-a559-607fb04e7f3f12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-134CHOLESTYRAMINE POWDER, FOR SUSPENSION [AJANTA PHARMA USA INC.]4Current NDC, Legacy NDC, 3 package rows20211124_a0b64dfe-49bc-45d7-9281-9e9d6e296c40.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSNa0b64dfe-49bc-45d7-9281-9e9d6e296c406
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCDa0b64dfe-49bc-45d7-9281-9e9d6e296c406
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSYa0b64dfe-49bc-45d7-9281-9e9d6e296c406
848943cholestyramine resin 4 GM Powder for Oral SuspensionSYa0b64dfe-49bc-45d7-9281-9e9d6e296c406

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-134-21272410134219 g in 1 PACKET9 gHistorical
27241-134-362724101343660 PACKET in 1 CARTON (27241-134-36) / 9 g in 1 PACKET (27241-134-21) 60 packet2020-04-060000-00-00NoNoCurrent
27241-134-5127241013451378 g in 1 BOTTLE (27241-134-51) 378 g2020-04-060000-00-00NoNoCurrent